Schering-Plough Asthma Devices Caused
Several Deaths, Consumer Advocates Say
Note: Notice reference to albuterol.
By JILL CARROLL and GARDINER HARRIS
Staff Reporters of THE WALL STREET JOURNAL
WASHINGTON -- In another blow to Schering-Plough Corp., a consumer-advocacy group says 17 people died because of what the group says were faulty asthma inhalers, some of which had been recalled due to concerns they didn't contain medicine.
The group, Public Citizen, sent a letter with its conclusions to Health and Human Services Department Secretary Tommy Thompson, urging criminal prosecution of the Kenilworth, N.J., company. The group in March told HHS it believed the company knowingly sold defective inhalers.
Bill O'Donnell, a Schering-Plough spokesman, said the company has "no evidence that a patient was ever harmed by an inhaler subject to any recalls" and that "every inhaler returned to the company by a patient claiming injury and alleging the canister lacked active ingredient has been tested and found to contain active ingredient."
The report is the first suggestion that Schering-Plough's persistent manufacturing woes may have hurt more than just company profit. It recalled 59 million inhalers in 1999 and 2000, mainly because it didn't have a quality-control system to guarantee they all contained albuterol, an asthma medication.
The Food and Drug Adminstration also has found a torrent of flaws at the company's plants in New Jersey and Puerto Rico over the past three years. Among the most serious of the problems was the occasional failure to insert medicine into its popular asthma-inhaler cans, marketed under the name Proventil.
Federal officials never stopped Schering-Plough from selling inhalers because the company controls much of the market and such a move could cause a shortage.
An FDA database analyzed by Public Citizen showed that of 17 people who died during asthma attacks while using Schering-Plough inhalers, at least 10 were patients using albuterol inhalers that were recalled by the company. Data on the other seven were insufficient to determine whether their inhalers had been recalled.
No deaths have been reported since the recalls were completed, Public Citizen said. The company first learned about a death believed to have resulted from a faulty inhaler in January 2000, the group said, but waited until March 2000 to issue another recall of the devices. Schering-Plough denies knowing of any deaths caused by faulty inhalers.
"Based on this new information concerning the deaths, there is even more reason for criminally prosecuting Schering-Plough for introducing these defective products into the marketplace and failing to recall them much earlier," wrote Sidney Wolfe, director of Public Citizen's health-research group, in the letter to Mr. Thompson.
The Public Citizen report examines data from the FDA's adverse-event reporting system, which at best provides clues about health dangers because the reports can be difficult to interpret and not all problems are reported.
The company is "vigorously contesting" lawsuits by patients claiming injury from recalled inhalers, Schering-Plough's Mr. O'Donnell said.
Schering-Plough announced earlier this year that the FDA, which has been dissatisfied with the company's response to agency concerns, refused to approve its sales of a new asthma drug until the company fixes its manufacturing problems. The drug, Clarinex, is the company's most important new product.
Separately, an alliance of consumer groups sued Schering-Plough, asserting the company used misleading advertising to market Claritin, America's most widely prescribed allergy drug. The suit, filed in New Jersey Supreme Court in Trenton, claims Schering-Plough's advertising pitch that Claritin works for everyone is false and that it boosted the demand, and price, for the drug. Schering-Plough declined to comment directly on the lawsuit.
In 4 p.m. composite trading Thursday on the New York Stock Exchange, Schering was off 10 cents at $38.25.
-- Christopher Windham contributed to this article. |
